Валеология: Здоровье, Болезнь, Выздоровление. 2019; : 53-59
ЛЕЧЕНИЕ ГЕСТАЦИОННОГО САХАРНОГО ДИАБЕТА
Аннотация
Гипергликемия во время беременности может привести к неблагоприятным исходам для матери, плода и новорожденного. На протяжении многих лет золотым стандартом фармакологической терапии во время беременности был человеческий инсулин. Недавно аналоги инсулина были также введены в клиническое применение при беременности. Представлены сильные и слабые стороны введения аналогов инсулина во время беременности по сравнению с человеческим инсулином. Согласно исследованиям беременных женщин с диабетом 1 типа, инсулины лиспро, аспарт и детемир эффективны и безопасны. Соответственно, FDA реклассифицировало их для лечения беременных женщин с диабетом из категории C в категорию B. Хотя по-прежнему отсутствуют большие и перспективные данные по инсулин-гларгину при беременности, никаких серьезных проблем безопасности не было задокументировано. При беременности не проводилось никаких контролируемых исследований с инсулинами глулизином и деглудеком. В целом, из-за снижения риска гипогликемии аналоги инсулина являются практическими терапевтическими вариантами для гипергликемии во время беременности.
Список литературы
1. American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2018 Jan; 41 (Suppl 1) : S 13-S 27
2. Lawrence J. M., Contreras R., Chen W., Sacks D. A. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially / ethnically diverse population of pregnant women, 1999-2005. Diabetes care 2008; 31 (5) : 899-904
3. Jensen D. M., Damm P., Moelsted-Pedersen L., Ovesen P., Westergaard J. G., Moeller M., et al. Outcomes in type 1 diabetic pregnancies: a nationwide, population-based study. Diabetes Care 2004; 27: 2819–2823
4. Evers IM, de Valk H. W., Visser G. H. Risk of complications of pregnancy in women with type 1 diabetes: nationwide prospective study in the Netherlands. BMJ 2004; 328: 915
5. Sibai B. M., Caritis S. N., Hauth J. C., MacPherson C., Van Dorsten J. P., Klebanoff M., et al. Preterm delivery in women with pregestational diabetes mellitus or chronic hypertension relative to women with uncomplicated pregnancies. The national institute of child health and human development maternal-fetal medicine units network. Am J Obstet Gynecol 2000; 183 (6) : 1520-4
6. Page R. C., Kirk B. A., Fay T., Wilcox M., Hosking D. J., Jeffcoate W. J. Is macrosomia associated with poor glycaemic control in diabetic pregnancy? Diabet Med 1996; 13 (2) : 170-4 18
7. de Veciana M., Major C. A., Morgan M. A., Asrat T., Toohey J. S., Lien J. M. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med 1995; 333: 1237–1241 10. Manderson J. G., Patterson C. C., Hadden D. R., Traub A. I., Ennis C., McCance D. R. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Am J Obstet Gynecol 2003; 189: 507–512
8. Jovanovic-Peterson L., Peterson C. M., Reed G. F., Metzger B. E., Mills J. L., Knopp R. H., Aarons J. H. Maternal postprandial glucose levels and infant birth weight: the Diabetes in Early Pregnancy Study. The National Institute of Child Health and Human Development – Diabetes in Early Pregnancy Study. Am J Obstet Gynecol 1991; 164 (1 Pt 1): 103–111
9. Combs C. A., Gunderson E., Kitzmiller J. L., Gavin L. A., Main E. K. Relationship of fetal macrosomia to maternal postprandial glucose control during pregnancy. Diabetes Care 1992; 15: 1251–1257
10. Omori Y., Jovanovic L. Proposal for the reconsideration of the definition of gestational diabetes. Diabetes Care 2005; 28 : 2592-3
11. Blumer I., Hadar E., Hadden D. R., Jovanovič L., Mestman J. H., Murad M. H., et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2013 Nov; 98 (11) : 4227-49
12. NICE guideline. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period. National Institute for Health and Care Excellence, 2015. nice.org.uk/guidance/ng3
13. Knox C. A., Delaney J. A., Winterstein A. G. Anti-diabetic drug utilization of pregnant diabetic women in us managed care. BMC Pregnancy Childbirth 2014; 14 : 28
14. Kitzmiller J. L., Block J. M., Brown F. M., Catalano P. M., Conway D. L., Coustan D. R. Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes care 2008; 31 (5) : 1060-79
15. Toledano Y., Hadar E., Hod M. Safety of insulin analogues as compared with human insulin in pregnancy. Expert Opin Drug Saf. 2016 Jul; 15 (7) : 963-73
16. Mukerji G., Feig D. S. Pharmacological Management of Gestational Diabetes Mellitus. Drugs. 2017 Oct; 77 (16) : 1723-1732
17. Lambert K., Holt R. I. The use of insulin analogues in pregnancy. Diabetes Obes Metab 2013; 15 (10) : 888-900 20
18. Kjos S. L., Schaefer-Graf U., Sardesi S., Peters R. K., Buley A., Xiang A. H., et al. A randomized controlled trial using glycemic plus fetal ultrasound parameters versus glycemic parameters to determine insulin therapy in gestational diabetes with fasting hyperglycemia. Diabetes Care. 2001; 24 (11) : 1904–10
19. Challier J. C., Hauguel S., Desmaizieres V. Effects of insulin on glucose uptake and metabolism in the human placenta. J Clin Endocrinol Metab. 1986; 62 (5) : 803
20. Canadian Diabetes Association Clinical Practice Guidelines Expert C, et al. Diabetes and pregnancy. Can J Diabetes. 2013; 37 (Suppl 1) : S 168–83
21. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977– 986
22. Blum A. K. Insulin Use in Pregnancy: An Update. Diabetes Spectr 2016; 29 (2) : 92-7
23. Pollex E. K., Feig D. S., Lubetsky A., Yip P. M., Koren G. Insulin glargine safety in pregnancy: a transplacental transfer study. Diabetes Care. 2010; 33 (1) : 29–33
24. Kurtzhals P., Schäffer L., Sørensen A., Kristensen C., Jonassen I., Schmid C., et al. Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes 2000; 49 (6) : 999–1005
25. Pöyhönen-Alho M., Rönnemaa T., Saltevo J., Ekblad U., Kaaja R. J. Use of insulin glargine during pregnancy. Acta Obstet Gynecol Scand. 2007; 86 : 1171–1174
26. Pollex E., Moretti M. E., Koren G., Feig D. S. Safety of insulin glargine use in pregnancy: a systematic review and meta-analysis. Ann Pharmacother. 2011; 45 (1) : 9–16 21
27. Fang Y. M., MacKeen D., Egan J. F., Zelop C. M. Insulin glargine compared with neutral protamine Hagedorn insulin in the treatment of pregnant diabetics. J Matern Fetal Neonatal Med. 2009; 22 : 249–253
28. Suffecool K., Rosenn B., Niederkofler E. E., Kiernan U. A., Foroutan J., Antwi K., et al. Insulin detemir does not cross the human placenta. Diabetes Care. 2015; 38 (2) : e20–1
29. Mathiesen E. R., Hod M., Ivanisevic M., Duran Garcia S., Brøndsted L., Jovanovic L., et al. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012; 35 : 2012–2017
30. Hod M., Mathiesen E. R., Jovanovič L., McCance D. R., Ivanisevic M., Durán-Garcia S., et al. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med 2014; 27 (1) : 7–13
31. Callesen N. F., Damm J., Mathiesen J. M., Ringholm L., Damm P., Mathiesen E. R. Treatment with the longacting insulin analogues detemir or glargine during pregnancy in women with type 1 diabetes: comparison of glycaemic control and pregnancy outcome. J Matern Fetal Neonatal Med. 2013; 26 (6) : 588–592
32. Koren R., Toledano Y., Hod M. The use of insulin detemir during pregnancy: a safety evaluation. Expert Opin Drug Saf 2015; 14 (4) : 593–9
33. Herrera K. M., Rosenn B. M., Foroutan J., Bimson B. E., Al Ibraheemi Z., Moshier E. L., et al. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol 2015; 213 (3) : 426. e1–7
34. Koren R., Ashwal E., Hod M., Toledano Y.. Insulin detemir versus glyburide in women with gestational diabetes mellitus. Gynecol Endocrinol. 2016; 32 (11) : 916-9 22
35. Boskovic R., Feig D. S., Derewlany L., Knie B., Portnoi G., Koren G., et al. Transfer of insulin lispro across the human placenta: in vitro perfusion studies. Diabetes Care 2003; 26 (5) : 1390–4
36. Lapolla A., Dalfrà M. G., Spezia R., Anichini R., Bonomo M., Bruttomesso D., et al. Outcome of pregnancy in type 1 diabetic patients treated with insulin lispro or regular insulin: an Italian experience. Acta Diabetol 2008; 45 : 61–6
37. Durnwald C. P., Landon M. B. A comparison of lispro and regular insulin for the management of type 1 and type 2 diabetes in pregnancy. J Matern Fetal Neonatal Med 2008; 21 : 309–13
38. Di Cianni G., Volpe L., Ghio A., Lencioni C., Cuccuru I., Benzi L., et al. Maternal metabolic control and perinatal outcome in women with gestational diabetes mellitus treated with lispro or aspart insulin: comparison with regular insulin. Diabetes care 2007 Apr; 30 (4) : e11
39. Jovanovic L., Ilic S., Pettitt D. J., Hugo K., Gutierrez M., Bowsher R. R., et al. Metabolic and immunologic effects of insulin lispro in gestational diabetes. Diabetes Care 1999; 22: 1422–7
40. Lv S., Wang J., Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet 2015; 292 (4) : 749–56
41. Cypryk K., Sobczak M., Pertyńska-Marczewska M., Zawodniak-Szałapska M., Szymczak W., Wilczyński J., et al. Pregnancy complications and perinatal outcome in diabetic women treated with Humalog (insulin lispro) or regular human insulin during pregnancy. Med Sci Monit. 2004; 10 : I29–I32 23
42. Mecacci F, Carignani L, Cioni R, Bartoli E, Parretti E, La Torre P., et al. Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women. Eur J Obstet Gynecol Reprod Biol. 2003;111 (1) : 19–24
43. Hod M., Damm P., Kaaja R., Visser G. H., Dunne F., Demidova I., et al. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol 2008; 198 (2) : 186e 1–7
44. Mathiesen E. R., Kinsley B., Amiel S. A., Heller S., McCance D., Duran S., et al. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabetes Care. 2007; 30 (4) : 771–6
45. Heller S., Damm P., Mersebach H., Skjøth T. V., Kaaja R., Hod M., et al. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study. Diabetes Care 2010; 33 : 473–7
46. Pettitt D. J., Ospina P., Kolaczynski J. W., Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care 2003; 26 (1) : 183–6
47. Doder Z., Vanechanos D., Oster M., Landgraf W., Lin S. Insulin glulisine in pregnancy—experience from clinical trials and postmarketing surveillance. Eur Endocrinol 2015; 11 (1) : 17–20
48. Thalange N., Deeb L., Iotova V., et al. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes 2015; 16 (3) : 164–76 24
49. Russell-Jones D., Gall M. A., Niemeyer M., Diamant M., Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: a meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis 2015; 25: 898–905 59. Milluzzo A., Tumminia A., Scalisi N. M., Frittitta L., Vigneri R., Sciacca L.. Insulin degludec in the first trimester of pregnancy: Report of two cases. J Diabetes Investig 2017 Aug 2. doi: 10.1111/jdi.12721
50. Milluzzo, A., Tumminia, A., Scalisi, N. M., Frittitta, L., Vigneri, R., Sciacca, L. Insulin degludec in the first trimester of pregnancy: Report of two cases. J Diabetes Investig. 2017;
51. Valentine W. J., Palmer A. J., Erny-Albrecht K. M., Ray J. A., Cobden D., Foos V., et al. Cost-effectiveness of basal insulin from a US health system perspective: comparative analyses of detemir, glargine, and NPH. Adv Ther 2006; 23 (2) : 191–207.
Valeology: Health - Illnes - recovery. 2019; : 53-59
TREATMENT OF GESTATIONAL DIABETES
Abstract
Hyperglycemia during pregnancy can lead to adverse effects on the mother, fetus and newborn. For many years, the gold standard of pharmacological therapy during pregnancy has been human insulin. Recently, insulin analogues have also been introduced into clinical use during pregnancy. The strengths and weaknesses of the introduction ofinsulin analogues during pregnancy compared with human insulin are presented. According to studies of pregnant women with type 1 diabetes, insulins lispro, aspart and detemir are effective and safe. Accordingly, the FDA reclassified them for the treatment of pregnant women with diabetes from category C to category B. Although there is still no large and promising data on insulin glargine during pregnancy, no major safety issues have been documented. During pregnancy, no controlled studies were conducted with insulins glulisine and degludec. In general, due to the reduced risk of hypoglycemia, insulin analogues are practical therapeutic options for hyperglycemia during pregnancy.
References
1. American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2018 Jan; 41 (Suppl 1) : S 13-S 27
2. Lawrence J. M., Contreras R., Chen W., Sacks D. A. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially / ethnically diverse population of pregnant women, 1999-2005. Diabetes care 2008; 31 (5) : 899-904
3. Jensen D. M., Damm P., Moelsted-Pedersen L., Ovesen P., Westergaard J. G., Moeller M., et al. Outcomes in type 1 diabetic pregnancies: a nationwide, population-based study. Diabetes Care 2004; 27: 2819–2823
4. Evers IM, de Valk H. W., Visser G. H. Risk of complications of pregnancy in women with type 1 diabetes: nationwide prospective study in the Netherlands. BMJ 2004; 328: 915
5. Sibai B. M., Caritis S. N., Hauth J. C., MacPherson C., Van Dorsten J. P., Klebanoff M., et al. Preterm delivery in women with pregestational diabetes mellitus or chronic hypertension relative to women with uncomplicated pregnancies. The national institute of child health and human development maternal-fetal medicine units network. Am J Obstet Gynecol 2000; 183 (6) : 1520-4
6. Page R. C., Kirk B. A., Fay T., Wilcox M., Hosking D. J., Jeffcoate W. J. Is macrosomia associated with poor glycaemic control in diabetic pregnancy? Diabet Med 1996; 13 (2) : 170-4 18
7. de Veciana M., Major C. A., Morgan M. A., Asrat T., Toohey J. S., Lien J. M. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med 1995; 333: 1237–1241 10. Manderson J. G., Patterson C. C., Hadden D. R., Traub A. I., Ennis C., McCance D. R. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Am J Obstet Gynecol 2003; 189: 507–512
8. Jovanovic-Peterson L., Peterson C. M., Reed G. F., Metzger B. E., Mills J. L., Knopp R. H., Aarons J. H. Maternal postprandial glucose levels and infant birth weight: the Diabetes in Early Pregnancy Study. The National Institute of Child Health and Human Development – Diabetes in Early Pregnancy Study. Am J Obstet Gynecol 1991; 164 (1 Pt 1): 103–111
9. Combs C. A., Gunderson E., Kitzmiller J. L., Gavin L. A., Main E. K. Relationship of fetal macrosomia to maternal postprandial glucose control during pregnancy. Diabetes Care 1992; 15: 1251–1257
10. Omori Y., Jovanovic L. Proposal for the reconsideration of the definition of gestational diabetes. Diabetes Care 2005; 28 : 2592-3
11. Blumer I., Hadar E., Hadden D. R., Jovanovič L., Mestman J. H., Murad M. H., et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2013 Nov; 98 (11) : 4227-49
12. NICE guideline. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period. National Institute for Health and Care Excellence, 2015. nice.org.uk/guidance/ng3
13. Knox C. A., Delaney J. A., Winterstein A. G. Anti-diabetic drug utilization of pregnant diabetic women in us managed care. BMC Pregnancy Childbirth 2014; 14 : 28
14. Kitzmiller J. L., Block J. M., Brown F. M., Catalano P. M., Conway D. L., Coustan D. R. Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes care 2008; 31 (5) : 1060-79
15. Toledano Y., Hadar E., Hod M. Safety of insulin analogues as compared with human insulin in pregnancy. Expert Opin Drug Saf. 2016 Jul; 15 (7) : 963-73
16. Mukerji G., Feig D. S. Pharmacological Management of Gestational Diabetes Mellitus. Drugs. 2017 Oct; 77 (16) : 1723-1732
17. Lambert K., Holt R. I. The use of insulin analogues in pregnancy. Diabetes Obes Metab 2013; 15 (10) : 888-900 20
18. Kjos S. L., Schaefer-Graf U., Sardesi S., Peters R. K., Buley A., Xiang A. H., et al. A randomized controlled trial using glycemic plus fetal ultrasound parameters versus glycemic parameters to determine insulin therapy in gestational diabetes with fasting hyperglycemia. Diabetes Care. 2001; 24 (11) : 1904–10
19. Challier J. C., Hauguel S., Desmaizieres V. Effects of insulin on glucose uptake and metabolism in the human placenta. J Clin Endocrinol Metab. 1986; 62 (5) : 803
20. Canadian Diabetes Association Clinical Practice Guidelines Expert C, et al. Diabetes and pregnancy. Can J Diabetes. 2013; 37 (Suppl 1) : S 168–83
21. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977– 986
22. Blum A. K. Insulin Use in Pregnancy: An Update. Diabetes Spectr 2016; 29 (2) : 92-7
23. Pollex E. K., Feig D. S., Lubetsky A., Yip P. M., Koren G. Insulin glargine safety in pregnancy: a transplacental transfer study. Diabetes Care. 2010; 33 (1) : 29–33
24. Kurtzhals P., Schäffer L., Sørensen A., Kristensen C., Jonassen I., Schmid C., et al. Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes 2000; 49 (6) : 999–1005
25. Pöyhönen-Alho M., Rönnemaa T., Saltevo J., Ekblad U., Kaaja R. J. Use of insulin glargine during pregnancy. Acta Obstet Gynecol Scand. 2007; 86 : 1171–1174
26. Pollex E., Moretti M. E., Koren G., Feig D. S. Safety of insulin glargine use in pregnancy: a systematic review and meta-analysis. Ann Pharmacother. 2011; 45 (1) : 9–16 21
27. Fang Y. M., MacKeen D., Egan J. F., Zelop C. M. Insulin glargine compared with neutral protamine Hagedorn insulin in the treatment of pregnant diabetics. J Matern Fetal Neonatal Med. 2009; 22 : 249–253
28. Suffecool K., Rosenn B., Niederkofler E. E., Kiernan U. A., Foroutan J., Antwi K., et al. Insulin detemir does not cross the human placenta. Diabetes Care. 2015; 38 (2) : e20–1
29. Mathiesen E. R., Hod M., Ivanisevic M., Duran Garcia S., Brøndsted L., Jovanovic L., et al. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012; 35 : 2012–2017
30. Hod M., Mathiesen E. R., Jovanovič L., McCance D. R., Ivanisevic M., Durán-Garcia S., et al. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med 2014; 27 (1) : 7–13
31. Callesen N. F., Damm J., Mathiesen J. M., Ringholm L., Damm P., Mathiesen E. R. Treatment with the longacting insulin analogues detemir or glargine during pregnancy in women with type 1 diabetes: comparison of glycaemic control and pregnancy outcome. J Matern Fetal Neonatal Med. 2013; 26 (6) : 588–592
32. Koren R., Toledano Y., Hod M. The use of insulin detemir during pregnancy: a safety evaluation. Expert Opin Drug Saf 2015; 14 (4) : 593–9
33. Herrera K. M., Rosenn B. M., Foroutan J., Bimson B. E., Al Ibraheemi Z., Moshier E. L., et al. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol 2015; 213 (3) : 426. e1–7
34. Koren R., Ashwal E., Hod M., Toledano Y.. Insulin detemir versus glyburide in women with gestational diabetes mellitus. Gynecol Endocrinol. 2016; 32 (11) : 916-9 22
35. Boskovic R., Feig D. S., Derewlany L., Knie B., Portnoi G., Koren G., et al. Transfer of insulin lispro across the human placenta: in vitro perfusion studies. Diabetes Care 2003; 26 (5) : 1390–4
36. Lapolla A., Dalfrà M. G., Spezia R., Anichini R., Bonomo M., Bruttomesso D., et al. Outcome of pregnancy in type 1 diabetic patients treated with insulin lispro or regular insulin: an Italian experience. Acta Diabetol 2008; 45 : 61–6
37. Durnwald C. P., Landon M. B. A comparison of lispro and regular insulin for the management of type 1 and type 2 diabetes in pregnancy. J Matern Fetal Neonatal Med 2008; 21 : 309–13
38. Di Cianni G., Volpe L., Ghio A., Lencioni C., Cuccuru I., Benzi L., et al. Maternal metabolic control and perinatal outcome in women with gestational diabetes mellitus treated with lispro or aspart insulin: comparison with regular insulin. Diabetes care 2007 Apr; 30 (4) : e11
39. Jovanovic L., Ilic S., Pettitt D. J., Hugo K., Gutierrez M., Bowsher R. R., et al. Metabolic and immunologic effects of insulin lispro in gestational diabetes. Diabetes Care 1999; 22: 1422–7
40. Lv S., Wang J., Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet 2015; 292 (4) : 749–56
41. Cypryk K., Sobczak M., Pertyńska-Marczewska M., Zawodniak-Szałapska M., Szymczak W., Wilczyński J., et al. Pregnancy complications and perinatal outcome in diabetic women treated with Humalog (insulin lispro) or regular human insulin during pregnancy. Med Sci Monit. 2004; 10 : I29–I32 23
42. Mecacci F, Carignani L, Cioni R, Bartoli E, Parretti E, La Torre P., et al. Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women. Eur J Obstet Gynecol Reprod Biol. 2003;111 (1) : 19–24
43. Hod M., Damm P., Kaaja R., Visser G. H., Dunne F., Demidova I., et al. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol 2008; 198 (2) : 186e 1–7
44. Mathiesen E. R., Kinsley B., Amiel S. A., Heller S., McCance D., Duran S., et al. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabetes Care. 2007; 30 (4) : 771–6
45. Heller S., Damm P., Mersebach H., Skjøth T. V., Kaaja R., Hod M., et al. Hypoglycemia in type 1 diabetic pregnancy: role of preconception insulin aspart treatment in a randomized study. Diabetes Care 2010; 33 : 473–7
46. Pettitt D. J., Ospina P., Kolaczynski J. W., Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care 2003; 26 (1) : 183–6
47. Doder Z., Vanechanos D., Oster M., Landgraf W., Lin S. Insulin glulisine in pregnancy—experience from clinical trials and postmarketing surveillance. Eur Endocrinol 2015; 11 (1) : 17–20
48. Thalange N., Deeb L., Iotova V., et al. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes 2015; 16 (3) : 164–76 24
49. Russell-Jones D., Gall M. A., Niemeyer M., Diamant M., Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: a meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis 2015; 25: 898–905 59. Milluzzo A., Tumminia A., Scalisi N. M., Frittitta L., Vigneri R., Sciacca L.. Insulin degludec in the first trimester of pregnancy: Report of two cases. J Diabetes Investig 2017 Aug 2. doi: 10.1111/jdi.12721
50. Milluzzo, A., Tumminia, A., Scalisi, N. M., Frittitta, L., Vigneri, R., Sciacca, L. Insulin degludec in the first trimester of pregnancy: Report of two cases. J Diabetes Investig. 2017;
51. Valentine W. J., Palmer A. J., Erny-Albrecht K. M., Ray J. A., Cobden D., Foos V., et al. Cost-effectiveness of basal insulin from a US health system perspective: comparative analyses of detemir, glargine, and NPH. Adv Ther 2006; 23 (2) : 191–207.
